Modeling and Simulation Associate Director - Pharmacokinetics, Dynamics, and Metabolism (PKDM)
Location
Piscataway, NJ | United States
Job description
Job Description
KP Recruiting Group is a consulting firm that provides leadership and exceptional talent to some of the world's leading companies. Headquartered in the Midwest, KP Recruiting Group has successfully completed countless engagements in the United States, Europe and Latin America. We represent clients in all industries and all sizes. Our mission is to provide exceptional client and candidate experiences in order to get the best possible results. On behalf of our client, we are excited to present the following confidential role. We look forward to hearing from you and discussing the opportunity!
The Role: The Modeling and Simulation Associate Director will support clinical phase project teams as a Modeling and Simulation (M&S) expert for the Pharmacokinetics, Dynamics, and Metabolism (PKDM) department in Development
- Conduct translational and population PK and PK/PD analysis, exposure-response analysis, clinical trial simulation, and/or other model-based analysis using different M&S software to characterize the kinetics of drug disposition and to assess the dynamics of drug effect
- Formulate and execute PK/PD and M&S strategies for specific projects to inform dose selection and go/no-go decisions
- Develop and apply state-of-the-art quantitative methodologies (mathematical, physiological or statistical M&S) to support clinical phase projects
- Develop and review protocols, analysis plans, and study reports for M&S aspects
- Prepare regulatory documents and representing M&S at regulatory meetings when needed
Knowledge and Skills:
1. Develop the following scientific skills:
- Perform population PK modeling, mechanistic PK/PD modeling, exposure-response analysis, clinical trial simulation, and/or other model-based analyses such as disease modeling, survival analysis, time to event analysis, and machine learning independently under minimal supervision
- Understand the strategic elements of drug development
- Apply a logical and structured approach to file management
- Develop departmental procedures (SOP's, Protocols, Safety Procedures)
- Train/mentor others
2. Demonstrate the following scientific competencies:
- Serve as M&S representative for clinical development projects
- Recommend a course of action to solve M&S issues
- Act as a resource to address technical and theoretical issues in the M&S area
- Be able to operate in a multicultural environment and participate in international teams
- Prepare analysis plans and/or protocols
- Prepare and issue stand-alone M&S reports with minimal review
- Summarize documents for submission to regulatory agencies, including but not limited to the FDA and EMA
- Can represent us to regulatory agencies
- Prepare abstracts, posters and manuscripts for external presentation and/or publication
- Present at external scientific meetings as appropriate
- Identify skill-sets necessary to advance career development
3. Ensure that all assigned project activities are performed in compliance with current departmental SOP's, guidelines, industry best practices and regulatory guidelines, and are conducted following acceptable scientific rationale.
- Demonstrate excellent leadership.
- Possess excellent interpersonal communications skills commensurate with working in a multicultural organization
Requirements - Ph.D. with or without post-doctoral experience in pharmacometrics, pharmaceutical sciences, clinical pharmacology, mathematics, statistics, computational biology, chemical/biomedical engineering, system pharmacology, computer science or closely related discipline plus at least 5 years of industrial experience with a record of increasing responsibility and independence.
- Technical expertise in several of the following areas: translational and population PK and PK/PD modeling and simulation, exposure-response modeling, clinical trial simulation, drug-disease modeling, PBPK modeling, time-to-event modeling, survival analysis, machine learning.
- Strong background in different M&S software such as NONMEM, R, Monolix, Phoenix NLME, ADPAT, Matlab, PKsim, SimCYP, SAS, Python, C/C++, Julia.
Benefits Our client offers a comprehensive benefits package including: 401k Matching
Family and Individual Insurance Packages (Health, Life, Dental, and Vision)
Paid Time Off & Paid Holidays
Long & Short-Term Disability
Identity Theft Plans
Retirement & Pension Plans
Employee Assistance Program
Employee Referral Program
Tuition Reimbursement Programs
Advancement & Professional Growth opportunities
Parental Leave
& More
Job tags
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